No patient involvement.The device was returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.
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It was reported that the centrimag motor started making rattling noise of some sort.The pump was reseated, but the noise continued.The motor was placed on mock loop and with movement of power wire on motor the rattling noise was produced.This event was previously not reported due to no patient information.Abbott made the decision on (b)(6) 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.
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